Viral Clearance Market Size, Share, Growth Analysis, By Type(Viral Removal Method, Viral Inactivation Method, Viral Detection Method), By Application(Recombinant Proteins, Blood, Blood Products, Vaccines), By End User(Pharmaceutical & Biotechnology Companies, Contract Research Organizations, Academic Research Institutes, Others), By Method(Viral Removal Method, Viral Inactivation Method, Viral Detection Method), By Region - Industry Forecast 2024-2031


Report ID: SQMIG35I2288 | Region: Global | Published Date: February, 2024
Pages: 260 |Tables: 120 |Figures: 77

Viral Clearance Market Insights

Viral Clearance Market size was valued at USD 492.9 billion in 2019 and is poised to grow from USD 535.6 billion in 2023 to USD 1519.7 billion by 2031, growing at a CAGR of 16.1% in the forecast period (2024-2031).

Viral clearance is the process of removal of viral particles and TSE (Transmissible spongiform encephalopathy) agents from the manufacturing process of development for monoclonal antibodies, recombinant proteins and glycoproteins, tissue, blood-derived products, and medical devices as these products are at risk from bacteria, chemical impurities, fungi, and from viruses. Viral contamination can affect cell culture processes, raw materials, bioreactor contamination, and downstream processing which in turn creates demand for viral safety practices. Increasing investments in the field of pharmaceutical and biotechnology and the rising demand for vaccines and other biotherapeutic agents are driving the market in the upcoming years.

US Viral Clearance Market is poised to grow at a sustainable CAGR for the next forecast year.

Market Snapshot - 2024-2031

Global Market Size

USD 492.9 billion

Largest Segment

Recombinant Proteins

Fastest Growth

Viral Removal Method

Growth Rate

16.1% CAGR

Global Viral Clearance Market ($ Bn)
Country Share for North America Region (%)

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Viral Clearance Market Segmental Analysis

Global Viral Clearance Market segmentation is based on method, application, end-user, and region. Based on the method, the Viral Clearance Market is segmented into the Viral Removal Method, Viral Inactivation Method, and Viral Detection Method. Based on Application, the Viral Clearance Market is segmented into Recombinant Proteins, Blood and Blood Products, Vaccines, and Others. Based on end-user, the Viral Clearance Market is segmented into Pharmaceutical & Biotechnology Companies, Contract Research Organizations, Academic Research Institutes, and Others. Based on Region the Viral Clearance Market is segmented into North America, Europe, Asia-Pacific, Latin America, and MEA.

Viral Clearance Market Analysis by Method

Based on the method, the market is segmented into the viral removal method, viral inactivation method, and viral detection method. Viral removal method segment accounted for the largest share in 2022. This segment may experience strong growth due to its efficiency and flexibility of the process. While in the upcoming years, the viral inactivation method segment is expected to grow faster due to increasing demand for new products like plasma proteins and gene therapy products. Lastly, the viral detection Method segment is expected to grow at a steady rate as this is the first step in the process of viral clearance this step will boost the growth of the segments of the market.

Viral Clearance Market Analysis by Application

Based on application, the market is segmented into recombinant proteins, blood and blood products, vaccines, and others. Vaccines accounted for a major share at a global scale and due to Covid-19 pandemic, the population realizes the importance of good health and have become conscious about their health. Increasing demand for the production of vaccines and immunization against chronic diseases such as hepatitis, cervical cancer, and others is boosting the growth of the vaccine segment.

Viral Clearance Market Analysis by End User

Based on end-user, the market is segmented into pharmaceutical & biotechnology companies, contract research organizations, academic research institutes, and others. The pharmaceutical & biotechnology companies segment accounted for a larger market share in 2022. The growth is the result of the mandate requirement of viral detection and viral inactivation during the development phase of biopharmaceuticals. This is projected to contribute to the segmental growth of the market in the upcoming years.

Global Viral Clearance Market By Application

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Viral Clearance Market Regional Insights

In 2022, North America dominated the market by accounting for over 35% of the market share owing to the rapidly growing innovation in biotechnology and Life sciences. Growth of pharmaceuticals, increase in number of drug approvals, investments in research and development, and accuracy and flexibility of method in life sciences research has shaped the market growth in these areas. 
The growing prevalence of illnesses and an increased production of monoclonal antibodies, and government assistance for medication development are some of the primary reasons driving the viral clearance industry in the US with increasing pharmaceutical production supporting the growth of the region. Europe is expected to follow North America due to the strong foundation of research and development and pharmaceuticals and is expected to capture the second-largest share of the market.

Asia Pacific may exhibit a larger growth in upcoming years owing to an increase in the processes of development and manufacturing of generics and the rise in government investments for medical research and the presence of CROs in the countries like China, Japan, and Malaysia. While Latin America and the Middle East regions are likely to observe modest growth due to the rising health expenditures and increasing demand for biopharmaceuticals.

Global Viral Clearance Market By Region
  • Largest
  • Fastest

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Viral Clearance Market Dynamics

Viral Clearance Market Driver

Increase in Demand for Biologics and Vaccines to Boost the Market Growth

  • The product safety procedures include the assessment of viral safety. Particularly for IND and BLA approvals, regulatory bodies place a strong emphasis on viral safety and demand high-quality data in support. Expertise in the key areas of these processes, and familiarity with the regulatory requirements and the process itself are crucial for strategic planning and can result in time, effort, and financial savings.
  • Another aspect that propels the expansion of viral inactivation market includes the rising frequency of chronic viral infections, illnesses, and the rising desire for effective treatment methods. Additionally, the market is expected to develop as a result of the growing investment in life sciences industry, followed with the introduction of innovative and classified drugs.

Viral Clearance Market Restraint

Significant Costs and Lack of Skilled Specialists to Impede the Market Growth

  • The high costs of novel technologies of viral clearance studies can restrict the market growth. High costs associated with the process and operations of Viral safety is itself causing constraint to the market. 
  • The lack of skilled specialists is rising the costs of overall processes. Managing finances and operational costs are becoming the limiting factor in the growth of the Viral Clearance Market.

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Viral Clearance Market Competitive Landscape

The key players in the viral clearance market are working on continuous innovation in the field of research and development and product portfolio enhancement for better therapeutic outcomes for consumers. For example, In November 2021, Wuxi biologics announced the official opening of its advanced therapies testing facility, including 140,000 sq. ft laboratories to enhance the company’s Contract Testing, Developing, and manufacturing Organization businesses to meet the increasing needs of customers in cell and gene therapy industry. Companies are also focusing on mergers and acquisitions to expand their businesses.

Viral Clearance Market Top Players Company Profiles

  • Charles River Laboratories International, Inc.
  • Merck KGaA
  • Wuxi AppTec Inc.
  • Eurofins Scientific
  • Avance Biosciences Inc.
  • Lonza Group AG
  • Sigma-Aldrich Corporation
  • Sartorius AG
  • Texcell, Inc.
  • Kedrion Biopharma Inc.
  • ViruSure GmbH
  • Clean Cells Inc.
  • Cytovance Biologics Inc.
  • GE Healthcare Life Sciences
  • Vironova AB
  • F. Hoffmann-La Roche Ltd.
  • BSL Bioservice Scientific Laboratories GmbH
  • Nelson Laboratories LLC
  • BioReliance Corporation
  • Novartis AG

Viral Clearance Market Recent Development

  • In June 2022, Asahi Kasei Medical is expanding into the CDMO business with the acquisition of Bay Area biologics maker Bionova Scientific for an undisclosed price. Like many in the industry, Japan-based Asahi Kasei has been on an expansion tear during the past few years. It purchased Austrian viral safety testing services provider Virusure Forschung und Entwicklung in 2019 and last year snapped up U.S-based mycoplasma testing services company Bionique Testing Labs.
  • In August 2021, WuXi Biologics announced that just 13 months after receiving its first GMP certificate, it has also received European Medicines Agency (EMA) GMP certificate for Biosafety testing center in Suzhou. This certificate demonstrates WuXi Biologics’ compliance with international cGMP safety assessment standards and regulatory guidelines.

Viral Clearance Key Market Trends

  • Growing Demand for Generics and Biosimilars: Increasing demand for biosimilars and generics is an ongoing trend. The need for sophisticated and cheap therapies for chronic diseases around the world is driving demand for recombinant non-glycosylation proteins in the biosimilars market; the application of cutting-edge technology to increase avenues.
  • Use of Single-use Systems and Disposable Technologies: The biopharmaceutical industry witnessed a high growth in the use of single-use systems and disposable technologies that have resulted in a huge demand for viral clearance services.

Viral Clearance Market SkyQuest Analysis

SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Co-relates, and Analyses the Data collected by means of Primary Exploratory Research backed by the robust Secondary Desk research.

According to the global viral clearance market report analysis, based on the method, the viral removal method dominated the global viral clearance market in 2022 and is anticipated to maintain its dominance throughout the forecast period. Whereas, North America dominated the global market by accounting for a greater market share owing to the National institutes supporting biotechnology and life sciences, growth of pharmaceuticals, and an increasing number of drug approvals.

Report Metric Details
Market size value in 2019 USD 492.9 billion
Market size value in 2031 USD 1519.7 billion
Growth Rate 16.1%
Base year 2023
Forecast period 2024-2031
Forecast Unit (Value) USD Billion
Segments covered
  • Type
    • Viral Removal Method, Viral Inactivation Method, Viral Detection Method
  • Application
    • Recombinant Proteins, Blood, Blood Products, Vaccines, Others
  • End User
    • Pharmaceutical & Biotechnology Companies, Contract Research Organizations, Academic Research Institutes, Others
  • Method
    • Viral Removal Method, Viral Inactivation Method, Viral Detection Method
Regions covered North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA)
Companies covered
  • Charles River Laboratories International, Inc.
  • Merck KGaA
  • Wuxi AppTec Inc.
  • Eurofins Scientific
  • Avance Biosciences Inc.
  • Lonza Group AG
  • Sigma-Aldrich Corporation
  • Sartorius AG
  • Texcell, Inc.
  • Kedrion Biopharma Inc.
  • ViruSure GmbH
  • Clean Cells Inc.
  • Cytovance Biologics Inc.
  • GE Healthcare Life Sciences
  • Vironova AB
  • F. Hoffmann-La Roche Ltd.
  • BSL Bioservice Scientific Laboratories GmbH
  • Nelson Laboratories LLC
  • BioReliance Corporation
  • Novartis AG
Customization scope

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Table Of Content

Executive Summary

Market overview

  • Exhibit: Executive Summary – Chart on Market Overview
  • Exhibit: Executive Summary – Data Table on Market Overview
  • Exhibit: Executive Summary – Chart on Viral Clearance Market Characteristics
  • Exhibit: Executive Summary – Chart on Market by Geography
  • Exhibit: Executive Summary – Chart on Market Segmentation
  • Exhibit: Executive Summary – Chart on Incremental Growth
  • Exhibit: Executive Summary – Data Table on Incremental Growth
  • Exhibit: Executive Summary – Chart on Vendor Market Positioning

Parent Market Analysis

Market overview

Market size

  • Market Dynamics
    • Exhibit: Impact analysis of DROC, 2021
      • Drivers
      • Opportunities
      • Restraints
      • Challenges
  • SWOT Analysis

KEY MARKET INSIGHTS

  • Technology Analysis
    • (Exhibit: Data Table: Name of technology and details)
  • Pricing Analysis
    • (Exhibit: Data Table: Name of technology and pricing details)
  • Supply Chain Analysis
    • (Exhibit: Detailed Supply Chain Presentation)
  • Value Chain Analysis
    • (Exhibit: Detailed Value Chain Presentation)
  • Ecosystem Of the Market
    • Exhibit: Parent Market Ecosystem Market Analysis
    • Exhibit: Market Characteristics of Parent Market
  • IP Analysis
    • (Exhibit: Data Table: Name of product/technology, patents filed, inventor/company name, acquiring firm)
  • Trade Analysis
    • (Exhibit: Data Table: Import and Export data details)
  • Startup Analysis
    • (Exhibit: Data Table: Emerging startups details)
  • Raw Material Analysis
    • (Exhibit: Data Table: Mapping of key raw materials)
  • Innovation Matrix
    • (Exhibit: Positioning Matrix: Mapping of new and existing technologies)
  • Pipeline product Analysis
    • (Exhibit: Data Table: Name of companies and pipeline products, regional mapping)
  • Macroeconomic Indicators

COVID IMPACT

  • Introduction
  • Impact On Economy—scenario Assessment
    • Exhibit: Data on GDP - Year-over-year growth 2016-2022 (%)
  • Revised Market Size
    • Exhibit: Data Table on Viral Clearance Market size and forecast 2021-2027 ($ million)
  • Impact Of COVID On Key Segments
    • Exhibit: Data Table on Segment Market size and forecast 2021-2027 ($ million)
  • COVID Strategies By Company
    • Exhibit: Analysis on key strategies adopted by companies

MARKET DYNAMICS & OUTLOOK

  • Market Dynamics
    • Exhibit: Impact analysis of DROC, 2021
      • Drivers
      • Opportunities
      • Restraints
      • Challenges
  • Regulatory Landscape
    • Exhibit: Data Table on regulation from different region
  • SWOT Analysis
  • Porters Analysis
    • Competitive rivalry
      • Exhibit: Competitive rivalry Impact of key factors, 2021
    • Threat of substitute products
      • Exhibit: Threat of Substitute Products Impact of key factors, 2021
    • Bargaining power of buyers
      • Exhibit: buyers bargaining power Impact of key factors, 2021
    • Threat of new entrants
      • Exhibit: Threat of new entrants Impact of key factors, 2021
    • Bargaining power of suppliers
      • Exhibit: Threat of suppliers bargaining power Impact of key factors, 2021
  • Skyquest special insights on future disruptions
    • Political Impact
    • Economic impact
    • Social Impact
    • Technical Impact
    • Environmental Impact
    • Legal Impact

Market Size by Region

  • Chart on Market share by geography 2021-2027 (%)
  • Data Table on Market share by geography 2021-2027(%)
  • North America
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • USA
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Canada
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
  • Europe
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • Germany
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Spain
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • France
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • UK
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Rest of Europe
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
  • Asia Pacific
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • China
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • India
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Japan
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • South Korea
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Rest of Asia Pacific
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
  • Latin America
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • Brazil
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Rest of South America
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
  • Middle East & Africa (MEA)
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • GCC Countries
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • South Africa
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Rest of MEA
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)

KEY COMPANY PROFILES

  • Competitive Landscape
    • Total number of companies covered
      • Exhibit: companies covered in the report, 2021
    • Top companies market positioning
      • Exhibit: company positioning matrix, 2021
    • Top companies market Share
      • Exhibit: Pie chart analysis on company market share, 2021(%)

Methodology

For the Viral Clearance Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:

1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.

2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Viral Clearance Market.

3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.

4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.

Analyst Support

Customization Options

With the given market data, our dedicated team of analysts can offer you the following customization options are available for the Viral Clearance Market:

Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.

Regional Analysis: Further analysis of the Viral Clearance Market for additional countries.

Competitive Analysis: Detailed analysis and profiling of additional Market players & comparative analysis of competitive products.

Go to Market Strategy: Find the high-growth channels to invest your marketing efforts and increase your customer base.

Innovation Mapping: Identify racial solutions and innovation, connected to deep ecosystems of innovators, start-ups, academics, and strategic partners.

Category Intelligence: Customized intelligence that is relevant to their supply Markets will enable them to make smarter sourcing decisions and improve their category management.

Public Company Transcript Analysis: To improve the investment performance by generating new alpha and making better-informed decisions.

Social Media Listening: To analyze the conversations and trends happening not just around your brand, but around your industry as a whole, and use those insights to make better Marketing decisions.

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FAQs

Viral Clearance Market size was valued at USD 492.9 billion in 2019 and is poised to grow from USD 535.6 billion in 2023 to USD 1519.7 billion by 2031, growing at a CAGR of 16.1% in the forecast period (2024-2031).

The key players in the viral clearance market are working on continuous innovation in the field of research and development and product portfolio enhancement for better therapeutic outcomes for consumers. For example, In November 2021, Wuxi biologics announced the official opening of its advanced therapies testing facility, including 140,000 sq. ft laboratories to enhance the company’s Contract Testing, Developing, and manufacturing Organization businesses to meet the increasing needs of customers in cell and gene therapy industry. Companies are also focusing on mergers and acquisitions to expand their businesses. 'Charles River Laboratories International, Inc.', 'Merck KGaA', 'Wuxi AppTec Inc.', 'Eurofins Scientific', 'Avance Biosciences Inc.', 'Lonza Group AG', 'Sigma-Aldrich Corporation', 'Sartorius AG', 'Texcell, Inc.', 'Kedrion Biopharma Inc.', 'ViruSure GmbH', 'Clean Cells Inc.', 'Cytovance Biologics Inc.', 'GE Healthcare Life Sciences', 'Vironova AB', 'F. Hoffmann-La Roche Ltd.', 'BSL Bioservice Scientific Laboratories GmbH', 'Nelson Laboratories LLC', 'BioReliance Corporation', 'Novartis AG'

Growing Demand for Generics and Biosimilars: Increasing demand for biosimilars and generics is an ongoing trend. The need for sophisticated and cheap therapies for chronic diseases around the world is driving demand for recombinant non-glycosylation proteins in the biosimilars market; the application of cutting-edge technology to increase avenues.

In 2022, North America dominated the market by accounting for over 35% of the market share owing to the rapidly growing innovation in biotechnology and Life sciences. Growth of pharmaceuticals, increase in number of drug approvals, investments in research and development, and accuracy and flexibility of method in life sciences research has shaped the market growth in these areas. The growing prevalence of illnesses and an increased production of monoclonal antibodies, and government assistance for medication development are some of the primary reasons driving the viral clearance industry in the US with increasing pharmaceutical production supporting the growth of the region. Europe is expected to follow North America due to the strong foundation of research and development and pharmaceuticals and is expected to capture the second-largest share of the market.

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